Compression; Vein, Edema Leg
Conditions
Brief summary
Device Efficacy: The primary efficacy assessment will be defined as successful if the edema volume will be reduced over time after using the SACS 2.0 device. Treatment and edema evaluation will be performed in comparison to a standard compression bandage. The treatment will be performed for several hours during the subject's daily rest time. The Measurements will be performed daily before treatment initiation and without the device on the leg (baseline) (T0); and after four hours of device operation. The edema volume will be measured by a calf circumference measurement.
Interventions
DEVICEElastiMed's SACS 2.0
A wearable medical device that improve circulation using smart materials
Sponsors
ElastiMed ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be between 18 to 80 years old 2. Venous edema patients diagnosed by an indent in the skin following finger pressure. 3. Venous edema in both calves 4. Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion 5. Subjects able to provide a written informed consent 6. No existence of DVT according to leg deep vein Duplex test
Exclusion criteria
as reported by patients: : 1. Positive pregnancy test 2. Breastfeeding woman 3. moderate or severe Congestive heart failure 4. Cellulitis of tissues of the lower limb. 5. Infectious Dermatitis of the lower limb 6. Acute or within 6 weeks of a deep vein thrombosis (DVT). 7. Postphlebetic patients 8. Known hypersensitivity to any component of the device 9. Subjects unable to provide informed consent 10. Active cancer at the root of the limb or in the adjacent quadrant 11. Any limitation of renal function- according to the investigator's discretion 12. Any limitation of liver function - according to the investigator's discretion 13. Subject who cannot commit to a month of intensive standard therapy 14. Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment 15. Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening 16. Other physical and/or mental conditions that, according to the investigator's discretion, prevent the subject from participating in the trial and completing its assessments 17. Cardiac or cerebral pacemaker or stimulator 18. Patients after orthopedic / vascular injury in the lower extremities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | Device operation hours during 10 business days | Accumulative rate of device related SAEs throughout the trial duration. |
| Efficacy Endpoint | Device operation hours during 10 business days | To demonstrate the efficacy by following the edema volume reduction after device application, in venous edema subjects, by measuring the calf circumference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint | Device operation hours during 10 business days | To demonstrate the efficacy by changing the edema volume after using the SACS 2.0 device at least as much as after using a compression bandage |
Countries
Israel
Contacts
Primary ContactVered Shuster, PhD
Backup ContactOmer Zelka
Outcome results
None listed